News

FDA invests $2 million in partnerships through Centers of Excellence in Regulatory Science and Innovation

Posted by Food and Drug Administration--Press Releases on Wednesday Oct 26, 2011 Under News

The U.S. Food and Drug Administration today announced the award of $2 million to support two regional Centers of Excellence in Regulatory Science and Innovation (CERSI).

The centers, which will be located at the University of Maryland and Georgetown University, will focus on strengthening science and training needed to modernize and improve the ways drugs and medical devices are reviewed and evaluated, a major focus within the FDA.

Tags : | Comments Off on FDA invests $2 million in partnerships through Centers of Excellence in Regulatory Science and Innovation

FDA, CMS launch pilot program for voluntary parallel review of innovative devices

Posted by Food and Drug Administration--Press Releases on Friday Oct 7, 2011 Under News

The U.S. Food and Drug Administration and the Centers for Medicare & Medicaid Services (CMS) today launched a “parallel review” pilot program for concurrent review of medical devices for FDA approval and Medicare coverage.

Tags : | Comments Off on FDA, CMS launch pilot program for voluntary parallel review of innovative devices

FDA approves combination therapy Juvisync

Posted by Food and Drug Administration--Press Releases on Friday Oct 7, 2011 Under News

The U.S. Food and Drug Administration today approved Juvisync (sitagliptin and simvastatin), a fixed-dose combination (FDC) prescription medication that contains two previously approved medicines in one tablet for use in adults who need both sitagliptin and simvastatin.

Tags : | Comments Off on FDA approves combination therapy Juvisync

FDA: New transparency report outlines proposals for enforcement data, for public comment

Posted by Food and Drug Administration--Press Releases on Monday Oct 3, 2011 Under News

The U.S Food and Drug Administration today released 8 new draft proposals in a report titled “Food and Drug Administration Transparency Initiative: Draft Proposals for Public Comment

Tags : | Comments Off on FDA: New transparency report outlines proposals for enforcement data, for public comment

FDA participates in global efforts to protect consumers and patients from unsafe drugs on the internet

Posted by Food and Drug Administration--Press Releases on Thursday Sep 29, 2011 Under News

The U.S. Food and Drug Administration and other regulatory and international partners have completed the International Internet Week of Action (IIWA), a cooperative effort to curb online sales and distribution of counterfeit and illegal medical products.

Tags : | Comments Off on FDA participates in global efforts to protect consumers and patients from unsafe drugs on the internet

FDA announces changes in drug center’s oncology office

Posted by Food and Drug Administration--Press Releases on Monday Sep 12, 2011 Under News

Today, the U.S. Food and Drug Administration announced organizational changes within the office responsible for reviewing all drug and biologic applications for cancer therapies. The Center for Drug Evaluation and Research’s (CDER) Office of Oncology Drug Products has been reorganized and renamed the Office of Hematology and Oncology Products (OHOP).

Tags : | Comments Off on FDA announces changes in drug center’s oncology office

FDA Commissioner Margaret A. Hamburg’s Statement on the Passing of Dr. Charles Edwards

Posted by Food and Drug Administration--Press Releases on Wednesday Aug 31, 2011 Under News

FDA Commissioner Margaret A. Hamburg’s Statement on the Passing of Dr. Charles Edwards

Tags : | Comments Off on FDA Commissioner Margaret A. Hamburg’s Statement on the Passing of Dr. Charles Edwards

FDA approves Xalkori with companion diagnostic for a type of late-stage lung cancer

Posted by Food and Drug Administration--Press Releases on Friday Aug 26, 2011 Under News

The U.S. Food and Drug Administration today approved Xalkori (crizotinib) to treat certain patients with late-stage (locally advanced or metastatic), non-small cell lung cancers (NSCLC) who express the abnormal anaplastic lymphoma kinase (ALK) gene.

Tags : | Comments Off on FDA approves Xalkori with companion diagnostic for a type of late-stage lung cancer

FDA approves Botox to treat specific form of urinary incontinence

Posted by Food and Drug Administration--Press Releases on Wednesday Aug 24, 2011 Under News

The U.S. Food and Drug Administration today approved Botox (onabotulinumtoxinA) injection to treat urinary incontinence in people with neurologic conditions such as spinal cord injury and multiple sclerosis who have overactivity of the bladder.

Tags : | Comments Off on FDA approves Botox to treat specific form of urinary incontinence

FDA: Regulatory science plan positions agency to foster innovation through better science

Posted by Food and Drug Administration--Press Releases on Wednesday Aug 17, 2011 Under News

The U.S. Food and Drug Administration today released its “Strategic Plan for Regulatory Science,” calling for a sweeping modernization of the science used in developing and evaluating products critical to the nation’s health, economy, and security.

Tags : | Comments Off on FDA: Regulatory science plan positions agency to foster innovation through better science